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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY RADICAL-7 HANDHELD; OXIMETER
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MASIMO - 52 DISCOVERY RADICAL-7 HANDHELD; OXIMETER Back to Search Results
Model Number 23786
Device Problem Inappropriate or Unexpected Reset (2959)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/05/2020
Event Type  malfunction  
Manufacturer Narrative
Additional manufacturing narrative: attempts have been made to obtain the product.The product has not been returned to masimo to allow an analysis to be performed.If the product is returned for evaluation or new information is obtained, a follow up report will be submitted., (b)(6).
 
Event Description
The customer reported the device switches off during measurement.No consequences or impact to patient were reported.
 
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Brand Name
RADICAL-7 HANDHELD
Type of Device
OXIMETER
Manufacturer (Section D)
MASIMO - 52 DISCOVERY
52 discovery
irvine CA 92618
Manufacturer (Section G)
MASIMO - MEXICALI
industrial vallera de mexicali calzada del oro, no.2001
mexicali, baja california 21600
MX   21600
Manufacturer Contact
matofa fautua
52 discovery
irvine, CA 92618
9496978262
MDR Report Key10983567
MDR Text Key220720738
Report Number3011353843-2020-00200
Device Sequence Number1
Product Code DQA
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K110028
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Non-Healthcare Professional
Remedial Action Other
Type of Report Initial
Report Date 11/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number23786
Device Catalogue Number9500
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/18/2020
Initial Date FDA Received12/10/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/09/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
RC-4 CABLE; RDS-3
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